It has been found that many medical problems which affect individuals can be successfully treated by applying heat to the affected area. Although a variety of devices have been created for use by individuals to provide heat to a particular area of the body, no system has been achieved which is capable of providing reliable, controlled, repeatable delivery of a precise temperature level in an easily used and convenient form.
The use of heat therapy for many transitory problems, such as pains, muscle pulls, etc., has been practiced for many years. Typically, these maladies are treated with electrically heated pads, hot towels, and/or hot compresses.
In addition to these common maladies, other medical problems have been found to benefit from the direct application of heat to a particular location on the body. A prime example of such medical problems which has recently been found to be treatable with heat therapy is warts.
Warts are very common and have long presented problems to individuals due to the pain, discomfort and the cosmetic problems associated therewith. Although various methods and treatments have been developed over the years for reducing or eliminating the undesirable effects associated with warts, these prior art applications, treatments and methods have been incapable of eliminating or curing warts or the problems associated with them.
In order to understand the treatment of warts, it is important to know that the skin is divided into three layers, the epidermis, the dermis, and the subcutaneous tissue. The outer layer of the skin is called the epidermis, and varies in thickness from about 0.3 mm on the eyelids and flexural areas to 1.55 mm on the palms and soles. The outermost layer of the epidermis is the stratum corneum (horny layer), which is comprised of completely keratinized dead cells. The thickness of the stratum corneum varies greatly on different parts of the body, being thickest on the palms and soles and totally absent on the oral mucosa.
The bottommost layer of the epidermis, called the basal cell layer, rests upon the basement membrane separating the epidermis from the dermis. The basel cells are the only epidermal cells that proliferate. The basal cells proliferate and, by cell division, form the keratinocytes (squamous cell layer, stratum spinosum, spinous layer). The keratinocytes synthesize insoluble protein which remains in the cells and will eventually become a major component of the outer layer (the stratum corneum, horny layer). The keratinocytes continue to divide and to migrate from the bottommost layer to the outermost layer, until the cells finally die. In this process of keratinization, the cells continue to flatten and their cytoplasm appears granular (stratum granulosum, granular layer) until they finally die as they reach the surface to form the stratum corneum (horny layer).
Warts are known to be intra-epidermal tumors of the skin caused by infection with the human papilloma virus (HPV). The HPV induces an abnormal increase of cells in the skin tissue, commonly referred to as hyperplasia, with the hyperplasia being limited to the squamous epithelium. Typically, replication of the papilloma virus is confined to the nuclei of the upper layer of infected epidermal cells.
Many different methods and application systems have been developed to treat warts. However, none of them are uniformly effective. The most common treatments for eliminating warts are surgery (conventional or laser surgery), cryosurgery, or the application of different acidic or caustic chemicals in order to completely remove the affected area. However, for many individuals, these processes are as difficult or as uncomfortable as the wart condition itself. The warts may return, and patients may be left with pain and/or scar formation. Consequently, many individuals avoid these treatments and, instead, merely accept the discomfort associated with their warts. Unfortunately, when warts are left alone, they may also spread, as a viral-infectious process.
Various chemical compositions have been developed in an attempt to eliminate or reduce the size of the warts by inactivating or slowing the growth of the virus within the skin. In addition, other chemical compounds have been used to reduce or eliminate the overgrowth and keratinization of the wart and thereby lessen its sensitivity or tenderness. Unfortunately, these chemical compositions have been incapable of providing a universally successful treatment for warts and, at best, have only been partially successful.
It has long been known that temperature is an important factor in the development of warts, as well as in treating warts. It is also known that the vast majority of warts are produced by HPV types 1, 2, 3, and 4. These viruses prefer to produce lesions on the acral (end) parts of the body which are cooler than the rest of the body. Since the skin surface in general and the extremities of individuals, such as hands and feet, typically have temperatures of between about 24.degree. and 31.degree. C., (less than the body temperature) these locations are typical for the development of the wart virus. The anogenital warts and laryngeal warts tend to replicate in more warmer locations and are clearly well known as comprising a different HPV.
Various studies have shown that the local application of heat causes the virus organisms to be slowed or inactivated. One attempt to effectively apply heat as a wart treatment was the use of hot water baths, with the individual immersing the entire body part containing the wart into a hot water bath. In view of the inherent limitations of this system as well as its limited success, wide acceptance of hot water exposure was never realized.
In particular, one principal limitation found with hot water baths is the inherent difficulty in maintaining a constant temperature for long time periods. In addition, hot water baths are extremely difficult to employ since the entire body part, not only the wart, must be immersed into the hot water. This is particularly difficult since long time exposures are required, as well as repeated exposures several times a day. Furthermore, the hot water bath procedure is particularly hazardous to children due to the risk of severe burning.
Finally, hot water baths are not realistically practical due to the importance of precision in the application temperature. The application temperature is extremely important, since the leeway between a therapeutic temperature and a destructive temperature is very narrow. At 44.degree. C., a six-hour exposure is needed to cause blistering or irreversible damage to the basal layer of the epidermis. However, at 51.degree. C., an exposure of between about 3 to 5 minutes is sufficient to destroy the epidermis.
As is evident from this discussion, warts can be effectively treated if a dependable delivery system for providing heat therapy were available. Similarly, numerous other medical problems are also effectively treated using a similar dependable delivery system which provides controlled heat therapy.
Therefore, it is a principal object of the present invention to provide a delivery system for providing heat therapy which is easy to use and is highly effective in providing controlled temperature levels to any desired location on the skin or body of the user.
Another object of the present invention is to provide a delivery system for providing heat therapy having the characteristic features described above which is capable of providing a constant level of heat for extended periods of time.
Another object of the present invention is to provide a delivery system for providing heat therapy having the characteristic features described above which is easily used by a consumer and enables the heat delivery system to be retained in any desired position or location for any desired length of time.
A further object of the present invention is to provide a delivery system for providing heat therapy having the characteristic features described above which is capable of being constructed to be easily reused with removable and replaceable heating pads cooperatively associated therewith, whenever required.
Another object of the present invention is to provide a delivery system for providing heat therapy having the characteristic features described above which is capable of being constructed as a single-use system which is easily applied to the skin surface for attaining the desired heat benefits and then disposed after use.
Another object of the present invention is to provide a delivery system for providing heat therapy having the characteristic features described above which is capable of providing consistent, repeatable, reproducible, and reliable temperature levels in a convenient, easily attained manner.
Other and more specific objects will in part be obvious and will in appear hereinafter.